BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUVEIN

    MDR report key: 7825999 · Received August 29, 2018

    Report

    Report Number
    7825999
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 27, 2018
    Report Date
    August 27, 2018
    Manufacturer
    ACCUVEIN INC
    Product Code
    KZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THERE ARE SEVERAL WEAK POINTS IN THIS ROLL STAND ARM SYSTEM WHERE IT CAN AND HAS BROKE AT DIFFERENT PIVOT POINTS. THIS IS A DESIGN FAILURE ISSUE. THERE IS ALSO A STOPPER IN PLACE SO THAT THE ARM WILL NOT TURN 360 DEGREES, BUT THAT STOPPER HAS BROKEN IN THE PAST AND CAUSED THE WIRING TO RIP. MANUFACTURER RESPONSE FOR ROLL STAND, ACCUVEIN (PER SITE REPORTER). THEY JUST OFFER TO SELL US A REPLACEMENT AS THEY CONSIDER THESE TYPES OF FAILURES USER ABUSE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670334 ACCUVEIN DEVICE, VEIN LOCATION, LIQUID CRYSTAL KZA ACCUVEIN INC HF470

    Patients

    Seq Age Sex Outcome Treatment
    1